Endoscopic Retrograde Cholangiopancreatography (ERCP) is an endoscopic technique which involves the placement of a sideviewing instrument within the descending duodenum. The procedure eliminates the need for invasive surgical procedures for identifying biliary stones and other obstructions of the biliary and pancreatic ducts.
Utilizing this technique, the Papilla of Vater and common biliary duct are cannulated, contrast media injected, and pancreatic ducts and the hepatobiliary tree visualized radiographically or examined with a duodeno-fiberscope. Skilled medical practitioners can visualize approximately 90 to 95 percent of the biliary and pancreatic ducts using this technique.
ERCP is typically performed on an x-ray table. During the procedure, the patient's oropharynx is anesthetized with topical lidocaine, and the patient is sedated intravenously with diazepam. Atropine and glucagon are given intravenously to induce duodenal hypotonia.
The ERCP procedure has heretofore typically been performed by the endoscopic introduction of a single lumen catheter into the pancreatic and common biliary ducts of a patient. Such ERCP catheters have typically been constructed from teflon. At times, a spring wire guide may be placed in the lumen of the catheter to assist in cannulation of the ducts. A stylet, used to stiffen the catheter, must first be removed prior to spring wire guide insertion. The introduction of the spring wire guide eliminates the ability to inject contrast media, or makes it highly cumbersome.
To summarize the procedure, an EPCP catheter is initially inserted through the endoscope and into the biliary or pancreatic ducts. If diffficulty is encountered or if the operator so desires, a spring wire guide is threaded into the catheter to assist in the cannulation. After the catheter is inserted into the duct and threaded over the spring wire guide, the spring wire guide is removed. A radio-opaque contrast medium is then injected through the single lumen of the catheter in order to identify obstructions such as bile stones. Once located and identified, such stones can then be eliminated or destroyed by methods such as mechanical lithotripsy, utilizing a device such as Olympus BML-10/20 Mechanical Lithotriptor.
This method of performing ERCP has several disadvantages. Most notably, it relies upon the use of a single lumen catheter which is threaded over the spring wire guide or pushed by a stylet and then, upon the removal of the stylet spring wire guide, used for infusing radio-opaque contrast media or dye into the biliary and pancreatic ducts. Unfortunately, the process of withdrawing the stylet spring wire guide in order to clear the single lumen for contrast media or dye infusion, frequently repositions the Catheter. Thus, when the radio-opaque or contrast media is injected into the catheter, the catheter is often improperly positioned for proper fluoroscopy or x-ray visualization. Moreover, this method presents the further problem of having to repeatedly remove the stylet or an approximate six foot long spring wire guide, maintain its cleanliness and then reinsert it into the catheter. Finally, single lumen catheters frequently experience the problem of back-flow in which the radio-opaque dye is squirted back out the catheter and onto the administering medical professional.
The above problems often result in the need to repeat the procedure, and can lead to a time consuming exercise of trial and error. Multiple attempts at properly positioning the catheter and spring wire guide are often necessary. Because the ERCP procedure is performed under sedation, the additional time required for proper catheter positioning tends to increase the risk to the patient. Furthermore, because of the considerable expense of maintaining a procedure room, the use of single lumen ERCP catheters can add considerably to the expense of the procedure. Accordingly, ERCP procedures have heretofore been performed by only the most skilled endoscopists.
It would be desirable to provide a dual or multi-lumen ERCP catheter in which one lumen could be utilized to accommodate the spring wire guide or diagnostic or therapeutic device, and in which a second lumen could be utilized for contrast media or dye infusion. As noted above, most prior art biliary catheters have been constructed from teflon. While teflon possesses a low coefficient of friction and can be extruded into a catheter having a long passageway, teflon is an unsuitable material from which to construct a multiple lumen catheter for ERCP applications. Because it cannot be extruded properly, attempts at manufacturing a multiple lumen catheter from teflon have resulted in catheters having too narrow a wall thickness.
Furthermore, while other polymers such as polyurethane and polyamide can be extruded to form a dual-lumen catheter for ERCP, most polyurethanes are too soft for ERCP applications and will kink, bunch up or buckle in use. After such kinking occurs, the catheter is rendered inoperative for injecting contrast media or dye.
In view of the above problems, it would be desirable to provide a multi-lumen ERCP catheter in which one lumen may be utilized to inject a contrast media or dye and the second lumen may be utilized for spring wire guide insertion and threading or inserting other devices. It would also be desirable to provide a catheter having calibrated or digitized bands to determine precise points of insertion of the catheter. Such a catheter would facilitate both spring wire guide feeding and adjustment as well as the infusion of contrast media without the need to remove the spring wire guide. Such a catheter would be more hygienic and would further widen the pool of medical professionals who could perform ERCP procedures, and would reduce the time necessary to complete ERCP, thereby reducing the risks to the patient undergoing the procedure. Such a catheter would allow smooth manipulation of the guide wire and simultaneous contrast medium injection. This will result in safer more effective ERCP. Such a catheter may allow cannulation of the right and left hepatic ducts and cystic ducts. Such a catheter would also allow laser lithotripty in the bile duct while the simultaneous injection of contrast medium is taking place.